July 8, 2020 / 5:30 PM / a month ago

Russian firm gets approval for drug said to block coronavirus replication

MOSCOW (Reuters) - Russia has approved a new antiviral drug, Coronavir, to treat COVID-19 patients, its developer R-Pharm said on Wednesday, as Russia’s tally of infections hit 700,000.

FILE PHOTO: The ultrastructural morphology exhibited by the 2019 Novel Coronavirus (2019-nCoV), which was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China, is seen in an illustration released by the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, U.S. January 29, 2020. Alissa Eckert, MS; Dan Higgins, MAM/CDC/Handout via REUTERS

It said a clinical trial involving mild or medium-level cases had shown the drug to be highly effective in inhibiting replication of the new coronavirus.

“Coronavir is one of the first drugs in Russia and in the world that does not tackle the complications caused by SARS-CoV-2, but battles the virus itself,” the company’s statement said.

It said a clinical study showed improvement in 55% of outpatient cases on the seventh day of treatment with Coronavir, against 20% of those with standard etiotropic therapy - meaning treatment of cause rather than symptoms. R-Pharm said there was also a significant difference at 14 days.

By the fifth day of treatment, the novel coronavirus had been eliminated in 77.5% of patients who took the drug, R-Pharm said.

“Global clinical practice and the clinical study we conducted have confirmed that Coronavir puts a much more rapid stop to the infection as a result of its effective obstruction of the virus’s replication,” Mikhail Samsonov, R-Pharm’s medical director, was cited as saying.

Testing began in late May and over 110 outpatients have now received the treatment, the head of clinical trials at Russia’s Central Research Institute of Epidemiology, Tatyana Ryzhentsova, was cited as saying.

The drug is the third registered in Russia to treat the new coronavirus. The first, Avifavir, has been given to patients since June 11.

The health ministry gave its approval for Avifavir’s use under an accelerated process while clinical trials, held over a shorter period and with fewer people than in many other countries, were still under way.

In a statement on Wednesday, Russia’s RDIF sovereign wealth fund, which provided financial backing for Avifavir, said it had asked the ministry to approve the drug for use by patients treating COVID-19 at home.

It said second- and third-phase clinical trials, as well as data from the first month of hospital use, had demonstrated positive results when Avifavir was used in the early and middle stages of the illness.

Russia’s official nationwide case tally stood at 700,792 as of Wednesday, with 10,667 deaths.

Reporting by Andrew Osborn; Writing by Polina Ivanova; Editing by Kevin Liffey

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